Bio-Equivalence : Module 5


All research involving human subjects should be conducted in accordance with the ethical principles contained in the current version of the Declaration of Helsinki, including respect for persons, beneficence (“maximize benefits and minimize harms and wrongs”) and non-maleficence (“do no harm”). As defined by the current revision of the International Ethical Guidelines for Biomedical Research Involving Human Subjects issued by the Council for International Organizations of Medical Sciences (CIOMS), or laws and regulations of the country in which the research is conducted, whichever represents the greater protection for subjects. In India ICMR has framed Ethical guidelines for Biomedical Research on Human subjects to be followed.

The study protocol should be submitted well in advance to independent ethics committee (IEC) for their review and approval before commencement of study. The IECs should be multidisciplinary and multisectorial in composition. Independence and competence are the two hallmarks of an IEC. The number of persons in an ethics committee should be kept fairly small (8 – 12 members). It is generally accepted that a minimum of five persons is required to form the quorum without which a decision regarding the research should not be taken. The IEC should appoint from among its members a Chairman who should be from outside the Institution and not head of the same Institution to maintain the independence of the Committee. The Member Secretary should be from the same Institution and should conduct the business of the Committee. Other members should be a mix of medical/ non-medical, scientific and non-scientific persons including lay persons to represent the differed points of view.

As per revised Schedule Y of Drugs & Cosmetics Act, 1940, amended in 2005, the ethics committee approving drug trials should have in the quorum at least one representative from the following groups:

1. One basic medical scientist (preferably one pharmacologist).

2. One clinician

3. One legal expert or retired judge

4. One social scientist/ representative of non-governmental organisation/ philosopher/ ethicist/ theologian or a similar person

5. One lay person from the community

The Ethics Committee (EC) can have as its members, individuals from other institutions or communities with adequate representation of age and gender to safeguard the interests and welfare of all sections of the community/society.

It is mandatory to have Ethics Committee approval before initiation of clinical study. In India a clinical trial should also be registered in Clinical Trial Registry of India and also updated time to time.

Dr. Manoj Karwa


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